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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Daiichi Sankyo
Farmers Insurance

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078601

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NDA 078601 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Akorn, Akorn Inc, Aurobindo Pharma Ltd, Hospira, Inforlife, Mylan Asi, and Navinta Llc, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 078601
Applicant:Navinta Llc
Ingredient:ropivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 078601
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 078601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3140 N 0781-3140-14
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3142 N 0781-3142-14

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength150MG/30ML (5MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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